Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020229
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEUSTATIN | CLADRIBINE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/26/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Withdrawn FR Effective 11/03/2016
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/02/2012 | SUPPL-34 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020229Orig1s034ltr.pdf | ||
06/29/2006 | SUPPL-30 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020229s030ltr.pdf | |
08/22/2002 | SUPPL-21 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr021ltr.pdf | |
08/20/2002 | SUPPL-7 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf | |
08/20/2002 | SUPPL-4 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/02/2012 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf |